Menarini and NewAmsterdam Pharma Secure EU Approval for LDL-C Therapies

Menarini Group and NewAmsterdam Pharma have obtained European Commission approval for Ubeslo® (obicetrapib monotherapy) and Evlarco® (obicetrapib plus ezetimibe combination). These are designed for patients with primary hypercholesterolaemia and mixed dyslipidaemia. This marks the inaugural global regulatory approval of obicetrapib.

The EC approval is underpinned by Phase 3 trials (BROADWAY, BROOKLYN, TANDEM) demonstrating notable LDL-C reductions with both therapies. Obicetrapib alone reduced LDL-C by up to 40% and with ezetimibe shown to achieve nearly 50% reduction versus placebo. These results offer new therapeutic options for patients poorly served by existing therapies.

Under their licensing agreement, Menarini holds the commercialization rights in Europe, with NewAmsterdam receiving royalties on sales. This approval paves the way for further advancement of obicetrapib in other markets.